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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78765

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 22, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Maquet

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less.

Z-0490-2018
Recall number
Z-0490-2018
Initiated
May 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Maquet
Quantity
55 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
55 kits were distributed after their expiration date of September 2015.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

55 kits were distributed after their expiration date of September 2015.

Code information

Lot/batch number: 3000001571 UDI code: 607567206489

Distribution pattern

Distributed to the states of NM, CA, and IL.